MAUDE Adverse Event Report: ETHICON INC. PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erosion (1750); Hematoma (1884); Post Operative Wound Infection (2446); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: am j obstet gynecol.2011; 204 (74).E1 8.Doi: 10.1016/j.Ajog.2010.08.036.(b)(4).

Event Description

It was reported via journal article: "title:trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes" author : alfredo l.Milani, md; piet hinoul, md; judi m.Gauld, bsc; vanja sikirica, pharmd, mph; douglas van drie, md; michel cosson, md, phd citation: am j obstet gynecol.2011; 204 (74).E1 8.Doi: 10.1016/j.Ajog.2010.08.036 the objective of this prospective multi-center cohort study was to evaluate the anatomic and functional outcomes at 1-year following trocar-guided transvaginal prolapse repair using a partially absorbable mesh.A total of 127 patients with pelvic organ prolapse stage iii had surgery and were evaluated at 3 months and 1-year post-surgery compared with baseline.All patients underwent the standardized transvaginal mesh placement technique of prolift+m mesh.Depending on the site of prolapse, the mesh repair could be anterior, posterior, or total; in patients with an intact uterus, the total mesh was made.Reported complications included recurrence of prolapse (n-1) which required re-operation with new prolift+m mesh placement, utero-vaginal prolapse (n-1) which required vaginal hysterectomy, posterior vaginal wall prolapse (n-1) which required subsequent laparoscopic sacrocolpopexy, apical failure (n-1) which required subsequent laparoscopic sacrocolpopexy, wound infection (n-2), infected hematoma (n-1), and mesh exposure (n-13) in which partial mesh excision was required in 7 patients and treatment with topical estrogen was made in 6 patients.It was concluded that the results of this study are suggestive that this lightweight mesh provides anatomic support consistent with the original polypropylene mesh and demonstrate high functional improvements.

• Brand Name: PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7479261
• MDR Text Key: 107135968
• Report Number: 2210968-2018-72510
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K071512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention